6 days old

Sr. Associate Mfg Execution Systems

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    121956159
Amgen

Job ID: R-102354
Location: Juncos, PR, US 00777

Summary

Under minimal supervision, employee will perform operations in the AML 1 and AML 23 facilities production areas. Operations will be performed according to Standard Operating Procedures (SOPs).

The Sr Associate Mfg Execution Systems will provide technical leadership to the team under the direction of the area Manager and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Electronic Batch Records (EBR), Standard Operating Procedures (SOP'S), and technical reports.

SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  • Perform complex troubleshooting and assist in the review of documentation for assigned functions.
  • May participate on cross-functional teams and represent the MES team. Employee may also have the responsibility of owning NC/CAPA's.
  • May identify, recommend, and implement improvements related to routine functions.
  • Implement improvements and/or changes in MES (EBR, Equipment Management, and other functions as requested)
  • Ensure all actions are completed on time to ensure current schedule is maintained, accurate, and up to date
  • Facilitate meetings and track the pending activities required to support change control implementations.
  • Proactive communication regarding scheduling errors and issues - provide realistic solutions;
  • Represent MES team in cross-functional meetings and projects when require,
  • Track, analyze and report scheduling metrics on schedule adherence, task adherence, and root cause analysis as required.
  • Conduct training to AML 1 and AML 23 staff and share knowledge with other members of the MES team.
  • Hands on experience with Werum PAS|X configuration, testing and validation environments and ERP experience (e.g. SAP)
  • Assist in Global Harmonization statigic activities including but mo limited to validations


Basic education & experience

Master's Degree in Business Administration, or Engineering

Or

Bachelor's Degree in Business Administration, Science or Engineering & 2 years of Operations or IS experience

Preferred qualifications

  • Knowledge of level 2 systems integration
  • Knowledge of automated equipment and computers
  • CFR and Regulatory knowledge
  • Basic statistical mathematical skills
  • Ability to interpret and apply GMP knowledge
  • Ability to demonstrate technical writing capability
  • Strong troubleshooting skills on process equipment


The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes health insurance benefits, performance bonus an award-winning retirement plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.



PI121956159

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Posted: 2020-07-28 Expires: 2020-08-28

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Sr. Associate Mfg Execution Systems

Amgen
Juncos, Puerto Rico 00777

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